The European Commission has approved a label update for AstraZeneca PLC's diabetes drug Forxiga, expanding the medicine's marketing authorization to include positive cardiovascular outcomes.
Cardiovascular events such as heart attack or stroke are common complications of diabetes. AstraZeneca studied Forxiga's impact on cardiovascular and kidney health in type 2 diabetes patients during a phase 3 clinical trial called Declare-Timi 58. The trial enrolled 17,000 patients in 33 countries. A majority of participants did not have existing cardiovascular disease.
Patients taking Forxiga in the trial saw reduced hospitalization for heart failure or cardiovascular death when compared with placebo. Fewer cardiovascular events were noted in the Forxiga patients. However, this data was not statistically significant, meaning the secondary goal of the trial was not achieved.
Data from Declare-Timi 58 is also under review for inclusion on Forxiga's label in the U.S. and China. Forxiga is marketed in the U.S. as Farxiga.
Forxiga belongs to a class of drugs known as SGLT-2 inhibitors and is approved to improve glycemic control in adults with type 2 diabetes. This class of drugs, also known as gliflozin drugs, work by absorbing glucose via the kidneys so that excess glucose is passed out of the body via urination.